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EP4527333A1 - Dispositif médical avec un collecteur d'irrigation - Google Patents

Dispositif médical avec un collecteur d'irrigation Download PDF

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Publication number
EP4527333A1
EP4527333A1 EP24201716.8A EP24201716A EP4527333A1 EP 4527333 A1 EP4527333 A1 EP 4527333A1 EP 24201716 A EP24201716 A EP 24201716A EP 4527333 A1 EP4527333 A1 EP 4527333A1
Authority
EP
European Patent Office
Prior art keywords
irrigation
diverter
conduit
housing
spine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24201716.8A
Other languages
German (de)
English (en)
Inventor
Cuong Pham
Helee Mukul JOSHI
Thanh Nguyen
Keshava Datta
Arlene ZAVALA
Anand Rao
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biosense Webster Israel Ltd
Original Assignee
Biosense Webster Israel Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biosense Webster Israel Ltd filed Critical Biosense Webster Israel Ltd
Publication of EP4527333A1 publication Critical patent/EP4527333A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6858—Catheters with a distal basket, e.g. expandable basket

Definitions

  • the present technology relates generally to medical devices, and in particular medical probes with electrodes, and further relates to, but not exclusively, medical probes suitable for use to induce irreversible electroporation (IRE) of cardiac tissues.
  • IRE irreversible electroporation
  • Cardiac arrhythmias such as atrial fibrillation (AF) occur when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythm. Certain procedures exist for treating arrhythmia, including surgically disrupting the origin of the signals causing the arrhythmia and disrupting the conducting pathway for such signals. By selectively ablating cardiac tissue by application of energy via a catheter, it is sometimes possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another.
  • AF atrial fibrillation
  • RF ablation can have certain risks related to thermal heating which can lead to tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula.
  • Cryoablation is an alternative approach to RF ablation that generally reduces thermal risks associated with RF ablation. Maneuvering cryoablation devices and selectively applying cryoablation, however, is generally more challenging compared to RF ablation; therefore, cryoablation is not viable in certain anatomical geometries which may be reached by electrical ablation devices.
  • IRE irreversible electroporation
  • Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using nonthermal ablation methods.
  • IRE delivers short pulses of high voltage to tissues and generates an unrecoverable permeabilization of cell membranes. Delivery of IRE energy to tissues using multi-electrode probes was previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Pub. No. 2021/0169550A1 , 2021/0169567A1 , 2021/0169568A1 , 2021/0161592A1 , 2021/0196372A1 , 2021/0177503A1 , and 2021/0186604A1 , each of which are incorporated herein by reference.
  • Irrigation while employing IRE ablation, is required to ensure no thrombosis occurs.
  • an irrigation manifold for a medical device.
  • the irrigation manifold can include a housing extending along a longitudinal axis defining a housing lumen and a housing conduit offset from the housing lumen, the housing conduit being configured to connect with a main line irrigation tube.
  • the irrigation manifold can include a diverter defining a diverter lumen connecting with the housing to define an irrigation chamber.
  • the diverter can include a first shaft nesting within the housing lumen.
  • the diverter can include a diverter ring defining a plurality of diverter conduits disposed radially about the longitudinal axis and connecting with a distal end of the housing. Each diverter conduit is configured to connect with a diverter irrigation tube that routes a fluid to an end effector of the medical device.
  • an end effector for a medical device can include an irrigation manifold, at least one spine, and an actuator rod.
  • the irrigation manifold extends along a longitudinal axis and can include a housing and a diverter.
  • the housing defines a housing lumen and a housing conduit.
  • the diverter defines a diverter lumen, connects with the housing to define an irrigation chamber, and defines at least one diverter conduit. Fluid is configured to flow into the irrigation chamber via the housing conduit and out of the irrigation chamber via the at least one diverter conduit.
  • the at least one spine is connected to the irrigation manifold at a proximal end of the at least one spine and is configured to bow radially outward from the longitudinal axis and to move between an expanded configuration and a collapsed configuration.
  • the at least one diverter conduit is configured to route the fluid along the at least one spine.
  • the actuator rod passes through the housing lumen and the diverter lumen and is connected to a distal end of the at least one spine. The actuator rod is configured to move the at least one spine between the expanded configuration and the collapsed configuration.
  • the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ⁇ 20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 110%.
  • the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject technology in a human patient represents a preferred embodiment.
  • proximal indicates a location closer to the operator or physician whereas “distal” indicates a location further away to the operator or physician.
  • vasculature of a "patient,” “host,” “user,” and “subject” can be vasculature of a human or any animal.
  • an animal can be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc.
  • the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like).
  • the subject can be any applicable human patient, for example.
  • doctor can include a doctor, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.
  • IRE irreversible electroporation
  • PEF pulsed electric field
  • PFA pulsed field ablation
  • Ablating or ablation as it relates to the devices and corresponding systems of this disclosure is used throughout this disclosure in reference to non-thermal ablation of cardiac tissue for certain conditions including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation.
  • the term “ablate” or “ablation” also includes known methods, devices, and systems to achieve various forms of bodily tissue ablation as understood by a person skilled in
  • bipolar and unipolar when used to refer to ablation schemes describe ablation schemes which differ with respect to electrical current path and electric field distribution.
  • Bipolar refers to ablation scheme utilizing a current path between two electrodes that are both positioned at a treatment site; current density and electric flux density is typically approximately equal at each of the two electrodes.
  • Unipolar refers to ablation scheme utilizing a current path between two electrodes where one electrode having a high current density and high electric flux density is positioned at a treatment site, and a second electrode having comparatively lower current density and lower electric flux density is positioned remotely from the treatment site.
  • tubular As discussed herein, the terms “tubular”, “tube” and “shaft” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length.
  • the tubular/shaft structures are generally illustrated as a substantially right cylindrical structure.
  • the tubular/shaft structures may have a tapered or curved outer surface without departing from the scope of the present disclosure.
  • the present disclosure is related to systems, method or uses and devices for IRE ablation of cardiac tissue to treat cardiac arrhythmias.
  • Ablative energies are typically provided to cardiac tissue by a tip portion of a catheter which can deliver ablative energy alongside the tissue to be ablated.
  • Some example catheters include three-dimensional structures at the tip portion and are configured to administer ablative energy from various electrodes positioned on the three-dimensional structures. Ablative procedures incorporating such example catheters can be visualized using fluoroscopy.
  • a thermal technique such as radio frequency (RF) energy and cryoablation
  • RF radio frequency
  • cryoablation to correct a malfunctioning heart
  • cardiac electropotentials need to be measured at various locations of the myocardium.
  • temperature measurements during ablation provide data enabling the efficacy of the ablation.
  • the electropotentials and the temperatures are measured before, during, and after the actual ablation.
  • RF approaches can have risks that can lead to tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula.
  • Cryoablation is an alternative approach to RF ablation that can reduce some thermal risks associated with RF ablation.
  • maneuvering cryoablation devices and selectively applying cryoablation is generally more challenging compared to RF ablation; therefore, cryoablation is not viable in certain anatomical geometries which may be reached by electrical ablation devices.
  • the present disclosure can include electrodes configured for irreversible electroporation (IRE), RF ablation, and/or cryoablation.
  • IRE can be referred to throughout this disclosure interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA).
  • PEF pulsed electric field
  • PFA pulsed field ablation
  • IRE as discussed in this disclosure is a non-thermal cell death technology that can be used for ablation of atrial arrhythmias.
  • biphasic voltage pulses are applied to disrupt cellular structures of myocardium. The biphasic pulses are non-sinusoidal and can be tuned to target cells based on electrophysiology of the cells.
  • IRE In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to produce heat at the treatment area, indiscriminately heating all cells in the treatment area. IRE therefore has the capability to spare adjacent heat sensitive structures or tissues which would be of benefit in the reduction of possible complications known with ablation or isolation modalities. Additionally, or alternatively, monophasic pulses can be utilized.
  • Electroporation can be induced by applying a pulsed electric field across biological cells to cause reversable (temporary) or irreversible (permanent) creation of pores in the cell membrane.
  • the cells have a transmembrane electrostatic potential that is increased above a resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, the electroporation is reversable, meaning the pores can close when the applied pulse electric field is removed, and the cells can self-repair and survive. If the transmembrane electrostatic potential increases beyond the threshold potential, the electroporation is irreversible, and the cells become permanently permeable.
  • the cells die due to a loss of homeostasis and typically die by apoptosis.
  • cells of differing types have differing threshold potential. For instance, heart cells have a threshold potential of approximately 500 V/cm, whereas for bone it is 3000 V/cm. These differences in threshold potential allow IRE to selectively target tissue based on threshold potential.
  • the technology of this disclosure includes systems and methods for applying electrical signals from catheter electrodes positioned in the vicinity of myocardial tissue to generate a generate ablative energy to ablate the myocardial tissue.
  • the systems and methods can be effective to ablate targeted tissue by inducing irreversible electroporation.
  • the systems and methods can be effective to induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied with the electrodes is below the electric field threshold of the target tissue allowing cells to repair. Reversible electroporation does not kill the cells but allows a physician to see the effect of reversible electroporation on electrical activation signals in the vicinity of the target location.
  • Example systems and methods for reversible electroporation is disclosed in U.S. Patent Publication 2021/0162210 , the entirety of which is incorporated herein by reference.
  • the pulsed electric field, and its effectiveness to induce reversible and/or irreversible electroporation, can be affected by physical parameters of the system and biphasic pulse parameters of the electrical signal.
  • Physical parameters can include electrode contact area, electrode spacing, electrode geometry, etc. Examples presented herein generally include physical parameters adapted to effectively induce reversible and/or irreversible electroporation.
  • Biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, inter-pulse delay, total application time, delivered energy, etc.
  • parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various systems and methods of ablation including IRE are presented in U.S.
  • System 10 includes multiple catheters, which are percutaneously inserted by physician 24 through the patient's 23 vascular system into a chamber or vascular structure of a heart 12.
  • a delivery sheath catheter is inserted into the left or right atrium near a desired location in heart 12.
  • a plurality of catheters can be inserted into the delivery sheath catheter so as to arrive at the desired location.
  • the plurality of catheters may include catheters dedicated for sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated for ablating and/or catheters dedicated for both sensing and ablating.
  • IEGM Intracardiac Electrogram
  • An example medical device/probe e.g., a catheter 14, that is configured for sensing IEGM is illustrated herein.
  • Physician 24 brings a distal tip of catheter 14 (i.e., a basket assembly 28 in this case) into contact with the heart wall for sensing a target site in heart 12.
  • a catheter 14 with a distal basket assembly can be referred to as a basket catheter.
  • physician 24 would similarly bring a distal end of an ablation catheter to a target site for ablating.
  • Catheter 14 is an exemplary catheter that includes one and preferably multiple electrodes 26 optionally distributed over a plurality of spines 104 at basket assembly 28 and configured to sense the IEGM signals.
  • Catheter 14 may additionally include a position sensor embedded in or near basket assembly 28 for tracking position and orientation of basket assembly 28.
  • position sensor is a magnetic based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation.
  • Magnetic based position sensor may be operated together with a location pad 25 including a plurality of magnetic coils 32 configured to generate magnetic fields in a predefined working volume.
  • Real time position of basket assembly 28 of catheter 14 may be tracked based on magnetic fields generated with location pad 25 and sensed by magnetic based position sensor. Details of the magnetic based position sensing technology are described in U.S. Patent Nos. 5,391,199 ; 5,443,489 ; 5,558,091 ; 6,172,499 ; 6,239,724 ; 6,332,089 ; 6,484,118 ; 6,618,612 ; 6,690,963 ; 6,788,967 ; 6,892,091 , each of which are incorporated herein by reference.
  • System 10 includes one or more electrode patches 38 positioned for skin contact on patient 23 to establish location reference for location pad 25 as well as impedance-based tracking of electrodes 26.
  • impedance-based tracking electrical current is directed toward electrodes 26 and sensed at electrode skin patches 38 so that the location of each electrode can be triangulated via the electrode patches 38. Details of the impedance-based location tracking technology are described in US Patent Nos. 7,536,218 ; 7,756,576 ; 7,848,787 ; 7,869,865 ; and 8,456,182 , each of which are incorporated herein by reference.
  • a recorder 11 displays electrograms 21 captured with body surface ECG electrodes 18 and intracardiac electrograms (IEGM) captured with electrodes 26 of catheter 14.
  • Recorder 11 may include pacing capability for pacing the heart rhythm and/or may be electrically connected to a standalone pacer.
  • System 10 may include an ablation energy generator 50 that is adapted to conduct ablative energy to one or more of electrodes at a distal tip of a catheter configured for ablating.
  • Energy produced by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including monopolar or bipolar high-voltage DC pulses as may be used to effect irreversible electroporation (IRE), or combinations thereof.
  • RF radiofrequency
  • PFA pulsed-field ablation
  • IRE irreversible electroporation
  • Patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiological equipment, power supply and a workstation 55 for controlling operation of system 10.
  • Electrophysiological equipment of system 10 may include for example, multiple catheters, location pad 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11.
  • PIU 30 additionally includes processing capability for implementing real-time computations of location of the catheters and for performing ECG calculations.
  • Workstation 55 includes memory, processor unit with memory or storage with appropriate operating software loaded therein, and user interface capability. Workstation 55 may provide multiple functions, optionally including (1) modeling the endocardial anatomy in three-dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27, (2) displaying on display device 27 activation sequences (or other data) compiled from recorded electrograms 21 in representative visual indicia or imagery superimposed on the rendered anatomical map 20, (3) displaying real-time location and orientation of multiple catheters within the heart chamber, and (5) displaying on display device 27 sites of interest such as places where ablation energy has been applied.
  • One commercial product embodying elements of the system 10 is available as the CARTO TM 3 System, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618 USA.
  • FIG. 2 is a schematic pictorial illustration showing a perspective view of a medical device 14, such as a medical probe, with electrodes 26.
  • the medical device 14 includes, at its distal tip 28, an end effector 100.
  • the end effector 100 in the presently described example takes the form of a basket assembly that includes at least one spine 104.
  • Spines 104 may have elliptical (e.g., circular) or rectangular (that may appear to be flat) cross-sections, and include a flexible, resilient material (e.g., a shape-memory alloy such as nickel-titanium, also known as Nitinol) forming a strut.
  • a shape-memory alloy such as nickel-titanium, also known as Nitinol
  • the end effector 100 is connected to the rest of the medical probe 14 via an elongated shaft 200.
  • the elongated shaft 200 can be tubular in form and flexible, with certain portions being more flexible than others. For example, a tip portion can be made more flexible than the rest to allow the end effector 100 to be easily deflected.
  • the elongated shaft 200 can be formed from a flexible, biocompatible electrically insulative material such as polyamide-polyether (Pebax) copolymers, polyethylene terephthalate (PET), urethanes, polyimide, parylene, silicone, etc.
  • insulative material can include biocompatible polymers including, without limitation, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactive (PCL), poly(3-hydroxybutyrate-co-3 -hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonates, and polyanhydrides with the ratio of certain polymers being selected to control the degree of inflammatory response.
  • PEEK polyetheretherketone
  • PGA polyglycolic acid
  • PLGA poly(lactic-co-glycolic acid) copolymer
  • PCL polycaprolactive
  • PHBV poly(3-hydroxybutyrate-co-3 -hydroxyvalerate)
  • poly-L-lactide polydioxanone
  • polycarbonates and polyanhydrides with the ratio of certain polymers being selected to control the degree of inflammatory response.
  • the spines 104 may be formed integrally with a distal hub (referred to herein as crown 108), as seen in FIG. 3 , so as to form a unitary/monolithic spine framework 102.
  • the framework 102 can be formed from a plurality of spines 104 and crown 108 separately formed and connected together.
  • the framework 104 can be formed from a planar or cylindrical tube stock of material using any suitable method.
  • the framework 102 can be formed by cutting, laser cutting, stamping, etc.
  • the coil 116 can comprise a single axis sensor (SAS).
  • the coil 116 can comprise a dual axis sensor (DAS) or a triple axis sensor (TAS).
  • the coil 116 can comprise a conductive material wound in a coil or a coil formed into a flexible circuit.
  • the coil 116 can comprise electrical leads for conduction of current induced on the coil to the patient interface unit 30.
  • the jacket 106 can include a polymer.
  • the jacket 106 can be formed from a flexible, biocompatible electrically insulative material such as polyamide-polyether (Pebax) copolymers, polyethylene terephthalate (PET), urethanes, polyimide, parylene, silicone, etc.
  • insulative material can include biocompatible polymers including, without limitation, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactive (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonates, and polyanhydrides with the ratio of certain polymers being selected to control the degree of inflammatory response.
  • PEEK polyetheretherketone
  • PGA polyglycolic acid
  • PLGA poly(lactic-co-glycolic acid) copolymer
  • PCL polycaprolactive
  • PHBV poly(3-hydroxybutyrate-co-3-hydroxyvalerate)
  • poly-L-lactide polydioxanone
  • polycarbonates polyanhydrides with the ratio of certain polymers being selected to control the degree of inflammatory response.
  • jacket 106 is shown to be tubular in these figures, the jacket 106 can be shaped, scalloped, ribbed, ridged, concaved, convexed, or otherwise configured such that the overall profile of jacket 106 yields physical and/or mechanical properties, such as rigidity and flexion along multiple axes, required by the end effector 100, mentioned above.
  • a flexible sleeve 146 is provided over proximal end of the end effector 100 and an irrigation manifold 120 ( FIG. 3 ), which is discussed in greater detail below.
  • the spine(s) 104 are movable between an expanded configuration and a collapsed configuration.
  • the elongated shaft 200 connects the end effector 100 to a handle that, in use, the operator 24 can manipulate.
  • An actuator rod 202 is connected to the crown 108 to facilitate the expanding and collapsing of the spines 104.
  • the rod 202 can be translated along a longitudinal axis A1 to expand/collapse the spines 104.
  • one or more spines 104 can bow radially outwardly from the longitudinal axis A1.
  • the spine(s) 104, elongated shaft 200, and actuator rod 202 are arranged generally along the longitudinal axis A1 when the elongated shaft 200 is unbent.
  • FIG. 3 is a schematic pictorial illustration showing a perspective view of the end effector 100, the sleeve 146, coil 116, and annulus 114 removed for clarity.
  • the framework 102 has a distal end 102A (that includes the crown 108) and a proximal end 102B.
  • the proximal end 102B is connected with an irrigation manifold 120 that routes irrigation flow 300 therethrough via a fluid source 302 coupled to a main line irrigation tube 140, and is described in greater detail below.
  • FIG. 4 is a schematic pictorial illustration showing a detail perspective view of the framework distal end 102A.
  • the actuator rod 202 extends within a lumen in the crown 108, and the annulus 114 connects the actuator rod 202 to the crown 108 via locking cutouts 110 defined in the crown 108.
  • the actuator rod 202 also defines a lumen 204, which is coaxial with the longitudinal axis A1, through which various medical devices can be extended therethrough when in use, such as a mapping catheter or a guidewire.
  • each jacket 106 defines a spine channel 106A and an irrigation conduit 106B that are separated by a jacket wall 106C.
  • Each spine channel 106A and irrigation conduit 106B can span an entire length of the jacket 106.
  • the spines 104 extend through the spine channel 106A from the crown 108 and terminate, after exiting the spine channel 106A, at a spine proximal end 112 ( FIG. 5 ).
  • the irrigation conduit 106B routes fluid along the spine 104 and is described in greater detail below.
  • the irrigation manifold 120 includes a manifold housing 122 and an irrigation diverter 128 connected together and extending along the longitudinal axis A1. While shown as separate components, in some examples, the housing 122 and diverter 128 can be formed integrally. Thus, the term “connected” can also, in certain examples, be taken to mean “integral”. When connected, the housing 122 and diverter 128 define an irrigation chamber 144 ( FIGs. 7-10 ), which is discussed in greater detail below.
  • FIG. 7 is a schematic pictorial illustration showing a perspective view perspective view of the proximal end of the end effector 100, shown in cross-section to illustrate certain features of the disclosed technology.
  • FIG. 8 is a schematic pictorial illustration showing a cross-sectional view of the proximal end of the end effector 100, cut relative to line 8-8 in FIG. 2 .
  • FIG. 9 is a schematic pictorial illustration showing a cross-sectional view of the proximal end of the end effector 100, cut relative to line 9-9 in FIG. 2 .
  • FIG. 10 is a schematic pictorial illustration showing a cross-sectional view of the proximal end of the end effector 100, cut relative to line 10-10 in FIG. 3 .
  • the manifold housing 122 is generally cylindrical in form and defines a housing lumen 124 as well as a hollow portion (right side of the housing 122 relative to the orientation shown in FIGs. 8 and 9 ).
  • the housing lumen 124 is parallel or coaxial with the longitudinal axis A1.
  • a housing conduit 126 Offset axially from the housing lumen is a housing conduit 126 that connects with a main line irrigation tube 140.
  • the housing conduit 126 is formed in a proximal wall of the housing 122 that is adjacent the hollow portion.
  • the irrigation diverter 128 is generally cylindrical in form.
  • the irrigation diverter 128 includes a first diverter shaft 130, a diverter ring 132, and a second diverter shaft 136 that are all axially aligned along the longitudinal axis A1, with a diverter lumen 138 being defined therethrough.
  • the first diverter shaft 130 and second diverter shaft 136 are disposed on opposing sides of the diverter ring 132 along the longitudinal axis A1.
  • the spine coupler 130 encircles the second diverter shaft 136 to connect it thereto.
  • the first diverter shaft 130 nests within the housing lumen 124.
  • the diverter ring 132 has a larger outer diameter than the first diverter shaft 130 and the second diverter shaft 136 and defines one or more diverter conduits 134 radially disposed about and running along the longitudinal axis A1 and spaced about a circumferential periphery of the diverter ring 132.
  • the diverter conduits 134 are laterally offset from the longitudinal axis A1 and extend parallel thereto.
  • a lip 132A is also formed in an outer surface of the diverter ring 132. As seen particularly in FIGs. 7-9 , the lip nests with an inner annular surface of the manifold housing 122. Accordingly, due to the respective nestings of the first diverter shaft 130 and the diverter ring 132 with the manifold housing 122, the resulting space therebetween forms an irrigation chamber 144 that is annular in form.
  • the irrigation chamber 144 fluidically connects the main line irrigation tube 140 with the diverter conduits, and is discussed in greater detail below.
  • the actuator rod 202 is able to pass through the lumens 124, 138 and run at least partially through the elongated shaft 200.
  • each diverter conduit 134 is connected to a diverter irrigation tube 142. More specifically, a proximal end of each diverter irrigation tube 142 can be inserted into a respective diverter conduit 134 such that the diverter irrigation tube 142 extends away from the irrigation manifold 120 and towards the distal end of the end effector 100.
  • the diverter irrigation tubes 142 are oriented parallel to one another and the longitudinal axis A1. The diverter irrigation tubes 142 are disposed beyond the spine coupler 118 in a radial direction ( FIGs. 5 and 7-9 ).
  • the diverter irrigation tubes 142 are spaced further away from the longitudinal axis A1 than a distance of the spine coupler 118 to the longitudinal axis (i.e., the radius of the spine coupler 118). With reference to FIG. 5 , the diverter irrigation tubes 142 encircle the spine coupler 118 and the second diverter shaft 136.
  • the diverter irrigation tubes 142 can be classified into two sub-groups of tubes.
  • the diverter irrigation tubes 142 include first diverter irrigation tubes 142A and second diverter irrigation tubes 142B.
  • the diverter conduits 134 are generally grouped into sets of three, and a second diverter irrigation tube 142B is sandwiched between two adjacent first diverter irrigation tubes 142A. Accordingly, in the disclosed example, there is a 2:1 ratio of first diverter irrigation tubes 142A to second diverter irrigation tubes 142B, although other ratios may be employed without departing from the spirit and scope of the present disclosure.
  • each first diverter irrigation tube 142A is connected with/received by the irrigation conduit 106B of a respective jacket 106.
  • This connection results in a continuous fluid path from the irrigation chamber 144 to the irrigation conduits 106B.
  • irrigation fluid 300 from the fluid source 302 routes through the main line irrigation tube 140, into the irrigation manifold 120 (specifically, the irrigation chamber 144), through each first diverter irrigation tube 142 (only one path is shown in FIG. 3 for illustrative purposes), into each irrigation conduit 106B, and exiting into the patient 23 through or proximal the electrodes 26 disposed on each spine 104.
  • electrodes 26 can be configured to deliver ablation energy (IRE and/or RF) to tissue in heart 12. In addition to using electrodes 26 to deliver ablation energy, the electrodes 26 can also be used to determine the location of the end effector 100 and/or to measure a physiological property such as local surface electrical potentials at respective locations on tissue in heart 12. The electrodes 26 can be biased such that a greater portion of the electrode 26 faces outwardly from the end effector 100 such that the electrodes 26 deliver a greater amount of electrical energy outwardly away from the end effector 100 (i.e., toward the heart 12 tissue) than inwardly toward the end effector 100.
  • ablation energy IRE and/or RF
  • Examples of materials ideally suited for forming electrodes 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity which allows the minimal heat generated on the tissue (i.e., by the ablation energy delivered to the tissue) to be conducted through the electrodes to the back side of the electrodes (i.e., the portions of the electrodes on the inner sides of the spines), and then to the blood pool in heart 12.
  • the electrodes 26 may be provided with one or more outlets 26A ( FIG. 2 ) therethrough or immediately proximal thereto.
  • portions of the fluid 300 is allowed to exit through the outlets 26A, such that irrigation is provided directly at each electrode 26.
  • some irrigation fluid 300 can continue all the way down the jacket 106 past the most distal electrode 26 and exit proximal the annulus 114 (see FIG. 4 for reference).
  • the annulus 114 or another element can be configured to occlude the distal end of the irrigation conduit 106 to block fluid flow or be adjustable to selectively permit fluid flow out of the distal end as needed by the physician 24.
  • each second diverter irrigation tube 142B is not received by an irrigation conduit 106B. Rather, the second diverter irrigation tubes 142B terminate outside the conduits 106B such that irrigation fluid 300 is delivered directly to the patient 23, in use, as opposed to first being routed through a conduit. In the illustrated example, distal ends of the second diverter irrigation tubes 142B terminate near a proximal end of the jackets 106 along the longitudinal axis A1. As depicted in FIG.
  • irrigation fluid 300 that enters the irrigation chamber 144 is, in addition to being routed through the first diverter irrigation tubes 142A, routed through the second diverter irrigation tubes 142B to irrigate near a proximal end of the end effector 100.
  • the second diverter irrigation tubes 142B may be omitted.
  • the irrigation manifold 120 and diverter tubes 142 along with the irrigation conduits 106B formed in the jackets 106, enable even distribution of irrigation around the electrodes 26 while simultaneously providing a way to provide irrigation directly within a patient 23.
  • the presently disclosed technology can be modified in various ways without departing from the spirit and scope of the present disclosure.

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EP24201716.8A 2023-09-22 2024-09-20 Dispositif médical avec un collecteur d'irrigation Pending EP4527333A1 (fr)

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US18/473,148 US20250099167A1 (en) 2023-09-22 2023-09-22 Medical device with an irrigation manifold

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US20220370124A1 (en) * 2019-11-05 2022-11-24 Sirona Medical Technologies, Inc. Multi-modal catheter for improved electrical mapping and ablation
DE202023102290U1 (de) * 2022-04-28 2023-08-11 Biosense Webster (Israel) Ltd. Spülnabe für einen Ablationskatheter

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US5558091A (en) 1993-10-06 1996-09-24 Biosense, Inc. Magnetic determination of position and orientation
US6690963B2 (en) 1995-01-24 2004-02-10 Biosense, Inc. System for determining the location and orientation of an invasive medical instrument
US6332089B1 (en) 1996-02-15 2001-12-18 Biosense, Inc. Medical procedures and apparatus using intrabody probes
US6618612B1 (en) 1996-02-15 2003-09-09 Biosense, Inc. Independently positionable transducers for location system
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US6484118B1 (en) 2000-07-20 2002-11-19 Biosense, Inc. Electromagnetic position single axis system
US20050154386A1 (en) * 2001-09-19 2005-07-14 Curon Medical, Inc. Devices, systems and methods for treating tissue regions of the body
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US7848787B2 (en) 2005-07-08 2010-12-07 Biosense Webster, Inc. Relative impedance measurement
US7536218B2 (en) 2005-07-15 2009-05-19 Biosense Webster, Inc. Hybrid magnetic-based and impedance-based position sensing
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US8456182B2 (en) 2008-09-30 2013-06-04 Biosense Webster, Inc. Current localization tracker
US20170273738A1 (en) * 2016-03-23 2017-09-28 Biosense Webster (Israel) Ltd. Dispersed irrigation configuration for catheter tip design
US20220370124A1 (en) * 2019-11-05 2022-11-24 Sirona Medical Technologies, Inc. Multi-modal catheter for improved electrical mapping and ablation
US20210161592A1 (en) 2019-12-03 2021-06-03 Biosense Webster (Israel) Ltd. Pulse Generator for Irreversible Electroporation
US20210162210A1 (en) 2019-12-03 2021-06-03 Biosense Webster (Israel) Ltd. Using reversible electroporation on cardiac tissue
US20210169550A1 (en) 2019-12-05 2021-06-10 Biosense Webster (Israel) Ltd. Generating and interleaving of irreversible-electroporation and radiofrequnecy ablation (ire/rfa) waveforms
US20210169567A1 (en) 2019-12-09 2021-06-10 Biosense Webster (Israel) Ltd. Irreversible-electroporation (ire) balloon catheter with membrane-insulated high-voltage balloon wires
US20210169568A1 (en) 2019-12-09 2021-06-10 Biosense Webster (Israel) Ltd. Oriented irreversible-electroporation (ire) pulses to compensate for cell size and orientation
US20210177503A1 (en) 2019-12-11 2021-06-17 Biosense Webster (Israel) Ltd. Regulating delivery of irreversible electroporation pulses according to transferred energy
US20210186604A1 (en) 2019-12-24 2021-06-24 Biosense Webster (Israel) Ltd. Irreversible electroporation (ire) based on field, contact force and time
US20210196372A1 (en) 2019-12-31 2021-07-01 Biosense Webster (Israel) Ltd. Using irrigation on irreversible-electroporation (ire) electrodes to prevent arcing
DE202023102290U1 (de) * 2022-04-28 2023-08-11 Biosense Webster (Israel) Ltd. Spülnabe für einen Ablationskatheter

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CN119679496A (zh) 2025-03-25
IL315752A (en) 2025-04-01
US20250099167A1 (en) 2025-03-27

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